REGEN-COVTM (casirivimab (REGN10933) and imdevimab (REGN10987))
Dose Pack for 1 patient course
MUST ADMINISTER casirivimab and imdevimab together
Manufacturer: Regeneron Pharmaceuticals, Inc.
Distributor: AmerisourceBergen (a.k.a. ABC);
c19therapies@amerisourcebergen.com
Product: 2-drug monoclonal antibody cocktail for outpatient infusion
Emergency Use Authorization (EUA): 11/21/2020
Units: Supplied in 4 different Dose Packs, which contain the total number of vials of each antibody required to constitute one full patient course.
Imdevimab 1332 mg/11.1 ml carton
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Casirivimab 1332 mg/11.1 ml carton
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Imdevimab 300 mg/2.5 ml carton | 
Casirivmab 300 mg/2.5 ml carton |
DOSE PACK
NDC# |
Product in this dose pack |
Total vials
to constitute Patient therapy course |
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61755-035-02 | 1 vial of each antibody; Each vial contains 1332mg/11.1mL | 2 |
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61755-036-08 | 4 vials ofeach antibody; Each vial contains 300mg/2.5mL | 8 |
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61755-037-05 | 5 vials - 4 of one antibody and 1 of the other antibody; Mixed vial sizes (1) 1332mg/11.1mL and (4) 300mg/2.5mL | 5 |
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61755-038-05 | 5 vials - 4 of one antibody and 1 of the other antibody; Mixed vial sizes (1) 1332mg/11.1mL and (4) 300mg/2.5mL | 5 |
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Storage: Keep in carton until use. Unopened vials must be stored at refrigerated temperature (2oC–8oC/ 36°F–46°F) until use. Do not freeze, shake, or expose to direct light.
Earliest Expiration Date of Units Shipped: 06/2022
Dimension of a Single Dose Pack w/ Re-closable Bag: 12” x 15" x 2 (approx)"
Dimensions of Manufacturer's Case of Dose Pack w/ Case: 12”(d) x 12”(w) x 12”(h)
Dose Pack Information
Please note that each REGEN-COV dose pack contains the exact number of vials of casirivimab (REGN10933) and imdevimab (REGN10987) to prepare
ONE patient course of treatment.
Dose Pack Component |
Dose Pack Label |
Dose Pack Packaging |
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NDC: 61755-035-02 Dose-Pack Size: 2 Cartons - 1 vial of casirivimab
(1332mg/ 11.1mL) - 1 vial of imdevimab (1332 mg/ 11.1 mL)
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NDC: 61755-036-08 Dose Pack Size: 8 cartons - 4 vials of casirivimab
(300 mg/ 2.5 mL) - 4 vials of imdevimab
(300 mg/ 2.5 mL)
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NDC: 61755-037-05
Dose Pack Size: 5 cartons - 1 vial of casirivimab
(1332mg/ 11.1 mL) - 4 vials of imdevimab
(300mg/ 2.5 mL)
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|
|
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NDC: 61755-038-05
Dose Pack Size: 5 cartons - 4 vials of casirivimab antibody 300mg/ 2.5mL
- 1 vial of imdevimab antibody; 1332mg/ 11.1mL
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Individual Components:
Some sites may still have casirivimab and imdevimab on hand that were initially shipped as separate units for each component (i.e., non-dose pack).
Casirivimab (REGN10933) Injection (120 mg/ml)
MUST ADMINISTER WITH IMDEVIMAB (REGN10987)
Product: Single component of 2-drug monoclonal antibody cocktail for outpatient infusion
Units: Supplied in 2 volumes
- 1332 mg/11.1 ml single-dose vial in carton (10 ml from 1 vial needed for patient course)
- 300 mg/2.5 ml single-dose vials in cartons (10 ml; 2.5 ml from each of 4 vials needed for patient course)
Example: Casirivimab 1332 mg/11.1 ml carton |
Example: Casirivmab 300 mg/2.5 ml carton |
Dimensions of Single Vial in Carton: 1.7”(d) x 1.8”(w) x 2.8”(h)
Weight of a Single Vial in Carton: 1.5 oz. for 1332 mg/11.1 mL vial; 0.9 oz. for 300 mg/2.5 mL vial
Case: A full case contains 24 vials in cartons
Case Dimensions: 9.6”(d) x 7.4”(w) x 4.6”(h)
Case Weight: 2.7 lb. for 1332mg/11.1 mL vials; 1.8 lb. for 300 mg/2.5 mL vials
Imdevimab (REGN10987) Injection (120 mg/ml)
MUST ADMINISTER WITH CASIRIVIMAB (REGN10933)
Product: Single component of 2-drug monoclonal antibody cocktail for outpatient infusion
Units: Supplied in 2 volumes
- 1332 mg/11.1 ml single-dose vial in carton (10 ml from 1 vial needed for patient course)
- 300 mg/2.5 ml single-dose vials in cartons (10 ml; 2.5 ml from each of 4 vials needed for patient course)
Example: 1332 mg/ 11.1 ml carton |
Example: 300 mg/2.5 ml carton |
Storage: Keep in carton until use. Unopened vials must be stored at refrigerated temperature (2oC–8oC/36°F–46°F) until use. Do not freeze, shake, or expose to direct light.
Dimensions ofa Single Vial in Carton: 1.7”(d) x 1.8”(w) x 2.8”(h)
Weight of a Single Vial in Carton: 1.5 oz. for 1332 mg/11.1 mL vial; 0.9 oz. for 300 mg/2.5 mL vial prior to administration.
Administration:
For detailed guidelines, see "Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of REGEN-COVTM (casirivimab with imdevimab)"
Casirivimab and Imdevimab 2,400 mg Dose
a, Add:
Size of Prefilled 0.9% Sodium Chloride Infusion Bag | Maximum Infusion Rate | Minimum Infusion Time |
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50 ml
c | 210 mL/hr | 20 minutes |
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100 ml | 310 mL/hr | 23 minutes |
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150 ml | 310 mL/hr | 33 minutes |
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250 ml | 310 mL/hr | 52 minutes |
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Note: If immediate administration is not possible, store the diluted casirivimab with imdevimab infusion solution in the refrigerator between 2°C to 8°C (36°F to 46°F) for no more than 36 hours or at room temperature up to 25°C (77°F) for no more than 4 hours. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 30 minutes prior to administration
Resources/Links:
Regeneron webpage, including:
a 1,200 mg casirivimab and 1,200 mg imdevimab are added to the same infusion bag and administered together as a single intravenous infusion.
b After infusion is complete, flush with 0.9% Sodium Chloride Injection.
c The minimum infusion time for patients administered casirivimab with imdevimab together using the 50 mL prefilled 0.9% Sodium Chloride infusion bag must be at least 20 minutes to ensure safe use.